Accepted Manuscript

EUS-guided radiofrequency ablation for management of pancreatic insulinoma by

using a novel needle electrode (with videos)

Sundeep Lakhtakia, DM, Mohan Ramchandani, DM, Domenico Galasso, MD, Rajesh
Gupta, DM, Sushma Venugopal, MD, Rakesh Kalpala, DNB, D Nageshwar Reddy,
DM
PII: S0016-5107(15)02923-5
DOI: 10.1016/j.gie.2015.08.085
Reference: YMGE 9578

To appear in: Gastrointestinal Endoscopy

Received Date: 10 March 2015

Accepted Date: 7 August 2015

Please cite this article as: Lakhtakia S, Ramchandani M, Galasso D, Gupta R, Venugopal S, Kalpala R,
Reddy DN, EUS-guided radiofrequency ablation for management of pancreatic insulinoma by using a
novel needle electrode (with videos), Gastrointestinal Endoscopy (2015), doi: 10.1016/j.gie.2015.08.085.

This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to
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Title
EUS-guided radiofrequency ablation for management of pancreatic insulinoma by using a novel
needle electrode (with videos)

Authors
1. Sundeep Lakhtakia DM Asian Institute of Gastroenterology, Hyderabad, India.

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2. Mohan Ramchandani DM Asian Institute of Gastroenterology, Hyderabad, India.
3. Domenico Galasso MD Digestive Endoscopy Unit, A. Gemelli Hospital, Catholic
University of Sacred Heart, Rome, Italy.

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4. Rajesh Gupta DM Asian Institute of Gastroenterology, Hyderabad, India.
5. Sushma Venugopal MD Maimonides Medical Center, Brooklyn, NY, USA
6. Rakesh Kalpala DNB Asian Institute of Gastroenterology, Hyderabad, India

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7. D Nageshwar Reddy DM Asian Institute of Gastroenterology, Hyderabad, India

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Corresponding author
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Sundeep Lakhtakia
Department of Gastroenterology
Asian Institute of Gastroenterology
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6-3-661, Somajiguda,
Hyderabad - 500 082
India
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Phone: +91-40-2337 8888

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Fax : +91-40-2332 4255

Email : drsundeeplakhtakia@gmail.com
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Abstract

Background and Aims: Insulinomas are one of the most common functional pancreatic
neuroendocrine tumors (PNET). Surgical removal is the standard of care. Patients unfit for or
refusing surgery, need an alternative nonsurgical method to alleviate symptoms. EUS has been
used to localize, aspirate, and tattoo insulinomas, and to inject alcohol for local ablation. This

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study is aimed to assess the feasibility of EUS-guided radiofrequency ablation (EUS RFA) in
managing patients with a symptomatic insulinoma using a novel EUS RFA needle electrode.
Methods: The EUS RFA system used consists of a prototype 19G needle electrode, generator,

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and internal cooling system. EUS-guided RFA is performed under real-time visualization at 50
watts to ablate pancreatic insulinoma.
Results: In this observational human case series at a tertiary care center, 3 patients with

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symptomatic pancreatic insulinoma, not eligible for surgery, underwent EUS RFA using an
internally cooled prototype needle electrode. All had rapid symptomatic relief with biochemical
improvement and remained symptom free at 11 to 12 months of follow-up. There were no
procedure-related adverse events.

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Conclusions: EUS-guided RFA with the novel device can be considered in select patients of
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symptomatic pancreatic insulinoma, based on preliminary findings of beneficial effect without
adverse events. Assessment of the safety profile requires larger prospective trials.
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Insulinoma is the most common functional pancreatic neuroendocrine tumor (PNET), with
majority (90%) being small (< 2 cm) and benign. Associated debilitation is related to
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hypoglycemia secondary to excessive uncontrolled insulin production. Whipple’s triad helps

identify insulinomas. Raised fasting serum insulin and C-peptide assist in the diagnosis.
Surgery is the standard of care for PNET, with occasional adverse events including pancreatic
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fistulas and deep vein thrombosis leading to pulmonary embolism. Patients unfit for or refusing
surgery, require alternative treatment.1 Medical therapy is costly and may have significant
adverse effects. Embolization and ablation are options.2-25
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Background
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RFA has been used to treat abdominal tumors, including hepatic tumors.2,3 However, pancreatic
tissue is particularly sensitive to external insults, including heat, leading to slower adoption of
RFA in pancreatic tumors.4-11 Reported adverse events with RFA (pancreatitis, gastrointestinal
hemorrhage) are disputed.5,8,9,11 RFA with palliative surgery reportedly provided survival benefit
in unresectable pancreatic cancer patients.5
EUS RFA in pancreas of animals is feasible with acceptable incidence of pancreatitis.12-15 One
study suggested EUS RFA for managing small PNET.12
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Effective embolization of insulinomas was published three decades ago.16-18 Recently, successful
EUS guided ablation using ethanol injection was reported.19-21 RFA treatment of insulinomas has
been administered percutaneously under CT-guidance, intra-operatively or endoscopically under
EUS-guidance.22-25 To the best of our knowledge, only three cases were reported to date using
EUS RFA for management of insulinomas,24,25 and this report presents the first clinical cases
using a novel EUS RFA needle electrode in select patients with outcomes through 12 months.

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Methods
Patients

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The observational study, approved by the IRB in January 2014, included patients with
pancreatic insulinoma refusing surgery or unfit for it, after informed consent. To avoid any
thermal injury to adjacent normal pancreas, lesions bigger than 1 cm were preferred, so as to

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accommodate the entire 1 cm length of exposed needle electrode.
Materials
The EUS RFA system (Figure.1) (STARmed, Seoul, Korea) consists of:

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A) Prototype needle electrode: 19G, 140 cm long, covered with a sheath. The inner metallic
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part is insulated over its entire length except for the terminal 1 cm with a sharp conical tip
for energy delivery.
B) Generator (VIVA RF generator, STARmed, Seoul, Korea) with variable wattage
settings, is connected to the handle of needle electrode. Energy delivery is controlled by a
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foot switch.
C) Internal cooling system has two tubes connected to the needle electrode handle. The
‘inflow tube’ is connected via a pump to an external cold (0°C) saline solution bottle.
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Chilled saline solution circulates through the needle electrode during RFA procedure.
Warmed saline solution flows out through the ‘outflow tube’ into an external container.
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This continuous cooling mechanism prevents charring of the surface of the electrode,
improving accuracy of ablation.
Procedure
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The needle electrode is passed under EUS guidance into the target lesion transgressing minimum
of normal pancreatic tissue and avoiding pancreatic or bile duct. Puncture of interposing major
vessels is avoided using Doppler. The echogenic needle tip is positioned at the far end inside the
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lesion. The energy delivery (burn) was carefully applied only when the needle tip of electrode
was visualized within the margin of lesion on EUS.
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The energy setting was 50 watts. On pressing the foot paddle once, echogenic bubbles start
appearing around the needle tip indicating completeness of RFA at the site. The generator is then
switched off with the foot paddle. A coagulation necrosis area of about 10 to 12 mm by 5 mm is
produced in approximately 10 to 15 seconds. If needed, the electrode is repositioned under EUS
vision to ablate another proximal area along the same trajectory. Additional passes using a
fanning technique can be used to further ablate the same lesion. Efforts are made to first ablate
the most technically challenging segment of the lesion as visual artifacts may occur after
applying RFA. Completeness of ablation is assessed endosonographically.
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Results
Three patients with symptomatic insulinomas were treated using EUS RFA and followed for 11
to 12 months (February 2014 till January 2015). Table 1 provides patient and lesion
characteristics and procedure details. Table 2 summarizes key outcomes.
There were no adverse events related to procedure. Hypoglycemia with elevated fasting insulin
and C-peptide levels was documented before EUS RFA in all cases. Hypoglycemia relief was

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rapid with blood sugar levels at 80 to 100 mg/dL within 24 hours. Patients remained euglycemic
and asymptomatic at all visits through 11 to 12 months after insulinoma ablation.

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Case 1
A 42-year-old man with significant alcohol intake and cardiomyopathy presented with a 4-year

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history of recurrent seizures. Abdominal CECT failed to detect any pancreatic lesions. EUS
showed a well-defined pancreatic body lesion and early chronic pancreatitis in adjacent
parenchyma. On the first needle electrode pass, two areas in the same trajectory were ablated in
sequence from far to near end. On second pass, a more distal aspect of the lesion was targeted

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(Video 1) to achieve complete tumor ablation. The patient had rapid relief of hypoglycemia with
maintained normal blood sugar on serial monitoring. At 48 hours, serum insulin and C-peptide
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levels were reduced. A CECT and EUS examination at 8 months after RFA did not show any
visible pancreatic mass lesion. He remained asymptomatic through 12 months.
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Case 2
A 41-year-old man presented with recurrent hypoglycemia for one-year, leading to frequent
eating, including at night, causing weight gain to BMI of 46.8 kg/m2. Abdominal CECT showed
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an enhancing pancreatic genu lesion (Fig. 2A) confirmed on EUS (Fig. 2B). He underwent EUS
RFA of the insulinoma with resolution of hypoglycemia on the same day. During next 48 hours
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of hospital stay, he remained euglycemic without excessive hunger and significant reduction of
fasting insulin and C peptide levels. At 6 weeks, CECT showed a hypo-dense non-enhancing
lesion in genu of pancreas (Fig.3). At 6 months, fasting serum insulin and C-peptide levels were
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29.3 µU/ml and 4.1 ng/mL, respectively. At 12 months he remains asymptomatic with 18 kg
weight loss and a small residual lesion on EUS (Fig. 4).

Case 3
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A 52-year-old man presented with 2 years history of recurrent syncope from hypoglycemia.
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Abdominal CECT showed enhancing lesions in head and body of pancreas (Fig 5). EUS showed
a large hypoechoic lesion (22 x 19 mm) in head of pancreas close and inferior to the pre-
papillary pancreatic duct, with additional lesions in uncinate (5 mm), body (12 x 10 mm) and tail
(8 mm) (video 2). EUS-FNA cytology from the larger head lesion suggested benign PNET.
Presuming the pancreatic head lesion to be the principal culprit, transduodenal EUS RFA was
performed in short echoendoscope position. The needle electrode got deformed at completion of
the procedure, which was presumed due to the combination of factors: transduodenal access
route, the target PNET location in head of pancreas, and the need for 4 needle passes. He had no
further hypoglycemia. At 48 hours fasting insulin and C-peptide levels were normal and CECT
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showed peripheral rim enhancement. At 3 months, fasting serum insulin was 11.1 µU/mL.
Abdominal CECT still showed pancreatic head lesion with rim enhancement and central non-
enhancing hypodense area (Fig. 6). EUS showed peripheral hypoechoic lesion with irregular
anechoic and echogenic areas. He is asymptomatic at 11 months.

Discussion

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Our series provides early illustration of feasibility of EUS RFA for treatment of symptomatic
insulinomas using a novel EUS RFA needle electrode. Excellent beneficial effects seem

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immediate and maintained for several months without any adverse events. In selected patients for
whom surgery is not an option or who refuse surgery, EUS RFA seems a promising option. The
novel EUS RFA system used in this case series appears to provide very good procedural control.

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Procedural optimization and ultimately standardization will require multi-centric experience. In
addition, although no adverse events were observed in this small case series, this constitutes
insufficient assessment of the safety profile, which will need to be addressed in a larger
prospective trial.

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The obvious drawback of this ablative method is its palliative nature given the possibility of
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growth of remnant tumor. However, in patients unfit for or unwilling to undergo surgery but with
clinically debilitating symptoms, EUS RFA may offer an excellent management option.
Multicenter studies involving larger numbers with longer follow up are needed to establish
efficacy of this novel treatment method.
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References
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8. Wu Y, Tang Z, Fang H, et al. High operative risk of cool-tip radiofrequency ablation for
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the Main Pancreatic Duct Does Not Lead to Necrotizing Pancreatitis Pancreas 2014;43:938-
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insulinoma. JAMA. 1982; 248(11):1353-5.

17. Uflacker R. Arterial embolization as definitive treatment for benign insulinoma of the
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pancreas. J Vasc Interv Radiol. 1992; 3(4):639-44.

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24. Pai M, Habib N, Senturk H, et al. Endoscopic ultrasound guided radiofrequency ablation, for
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TABLE 1
Patient and Insulinoma Characterisitics and Procedure Details
Case 1 Case 2 Case 3
Age/Gender 42 year/male 41 year/ male 52 year/male

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Presentation Hypoglycemia with Hypoglycemia with Hypoglycemia with
recurrent episodes of frequent eating and recurrent episodes of
seizures for 4 years significant weight syncope for 2 years
gain for 1 year

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EUS-based Lesion Single hypoechoic Single hypoechoic Mutliple hypoechoic
Characteristics PNET at body; 14x12 PNET at genu; 17x12 PNETs in head, body,
mm; early signs of mm tail; largest PNET 22

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chronic pancreatitis x 19 mm in head
targeted for ablation
Reason for Refusing Risk associated with Risk associated with Concern over major

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Surgery poor cardiac status obesity surgery
EUS RFA - Access Transgastric Transgastric Transduodenal
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Route
EUS RFA - Needle
3 2 4
Electrode Passes
EUS RFA - Number
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4 3 8
of Ablation Areas
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TABLE 2
Laboratory Levels and Outcomes
Case 1 Case 2 Case 3
Blood
43 mg/dl 39 mg/dl 49 mg/dl
Sugar

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Fasting Insulin* 41.1 µIU/ml 51.2 µIU/ml 36.2 µIU/ml
EUS RFA
Pre

C- Peptide** 4.0 ng/ml 5.8 ng/ml 5.5 ng/ml

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Amylase 56 U/l 75 U/l 68 U/l

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Lipase 34 U/l 27 U/l 48 U/l

Adverse events None None None

Peri-EUS RFA

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Immediate

Amylase 92 U/l 102 U/l 93 U/l

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Lipase 99 U/l 78 U/l 88 U/l

Symptoms None None None

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Blood
Post EUS RFA

72 mg/dl 87 mg/dl 91 mg/dl

Sugar
48 hr

Fasting Insulin* 10.7 µIU/ml 19.8 µIU/ml 25.5 µIU/ml

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C-
2.4 ng/ml 3.6 ng/ml 4.0 ng/ml
Peptide**

3 mo 70 mg/dl 88 mg/dl 90 mg/dl

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Blood
5-6 mo 110 mg/dl 111 mg/dl 115 mg/dl
Sugar
11-12 mo 104 mg/dl 108 mg/dl 123 mg/dl
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Post EUS RFA
Mid Term

Fasting
9.8 µIU/ml 20.1 µIU/ml 12.9 µIU/ml
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11-12 mo
Insulin*
C-
11-12 mo 2.4 ng/ml 3.3 ng/ml 2.7 ng/ml
Peptide**
3 mo none none none

Symptoms 5-6 mo none none none

11-12 mo none none none

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*
Fasting serum insulin: Normal range 2.6 - 24.9 µIU/ml
** C-Peptide: Normal range 1.1 - 4.4 ng/ml

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Legends for figures:

1. a. Needle electrode (EUSRA).

b. Close-up of the tip of needle electrode showing the uncovered 1cm tip.
c. Needle electrode projecting out from the echoendoscope tip.

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d. Handle of needle electrode attached to accessory channel of the echoendoscope.
e. Viva Combo RFA generator – front view.
f. Viva Combo RFA generator – side view.

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g. Viva pump.

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2. A. Abdominal CECT in arterial phase shows enhancing lesion (Insulinoma) in the pancreatic genu
(arrow).

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2. B. Well defined hypoechoic oval shaped lesion (Insulinoma) in pancreatic genu (arrow).
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3. Post EUS RFA at 6 weeks. CECT shows a hypo-dense non-enhancing lesion in genu of pancreas
(arrow).
4. Post EUS RFA at 12 months. EUS shows a small residual hypoechoic lesion (arrow) with patchy
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echogenic areas.
5. Abdominal CECT in arterial phase shows a large enhancing lesion in head and genu of pancreas
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(arrow).
6. Post EUS RFA at 3 months. Abdominal CECT shows pancreatic head lesion with rim
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enhancement and central non-enhancing hypodense area (arrow).

Legends for Videos:

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1. EUS-guided needle electrode being passed inside the lesion, toward the far end, which is ablated
first followed by near end of the lesion. Appearance of white echogenic bubbles represents the
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completion of RFA at that site. Second pass is done within the lesion by fanning technique to
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ablate the distal aspect of lesion.

2. EUS shows a large vascular hypoechoic lesion (22 x 19 mm) in pancreatic head with additional
satellite lesions.
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Acronyms

EUS Endoscopic Ultrasound

RFA Radio Frequency Ablation

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EUS RFA Endoscopic Ultrasound guided Radio Frequency Ablation

PNET Pancreatic Neuro-Endocrine Tumor

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CT Computerized Tomography

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CECT Contrast Enhanced Computerized Tomography

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IRB Institutional Review Board AN
BMI Body Mass Index
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Author’s contribution

SL Performing the procedures, drafting the article and critically writing the manuscript.

MR Assistance during the EUS RFA procedure.

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DG Drafting the article and revising it critically.

RG Assistance during the EUS RFA procedure.

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SV Collecting the data, and drafting the article.

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RK Assistance during the EUS RFA procedure.

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DNR Contribution to the concept, and intellectual inputs.
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